A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole

Phase 1

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: AD-214 10/600mg; Drug: Rabeprazole 10mg

• Registration Number: NCT04494243
• Lead Sponsor: Addpharma Inc.

Brief Summary

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in healthy volunteers.

Detailed Description

This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214 10/600mg compared with administration of Rabeprazole 10mg in healthy volunteers.

Study Timeline

• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-07-31
• Study Start: 2020-08-28
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 19~50 years in healthy volunteers
• BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^2
• Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

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Exclusion Criteria

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
• Subjects who judged ineligible by the investigator

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AD-214/Rabeprazole	AD-214 10/600mg	Period 1 : Test Drug(AD-214 10/600mg) Period 2 : Reference Drug(Rabeprazole 10mg)
AD-214/Rabeprazole	Rabeprazole 10mg	Period 1 : Test Drug(AD-214 10/600mg) Period 2 : Reference Drug(Rabeprazole 10mg)
Rabeprazole/AD-214	AD-214 10/600mg	Period 1 : Reference Drug(Rabeprazole 10mg) Period 2 : Test Drug(AD-214 10/600mg)
Rabeprazole/AD-214	Rabeprazole 10mg	Period 1 : Reference Drug(Rabeprazole 10mg) Period 2 : Test Drug(AD-214 10/600mg)

Primary Outcome Measures

Name	Time	Method
AUCtau,ss(Area under the plasma drug concentration-time curve)	From Day 1 up to Day 29	Evaluateion PK Rabeprazole after multiple dose
Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)	Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring	Evaluation PD Rabeprazole after multiple dose

Secondary Outcome Measures

Name	Time	Method
Tmax(Time to maximum plasma concentration)	Day1	Evaluation PK Rabeprazole after single dose
t1/2(Terminal elimination half-life)	Day1	Evaluation PK Rabeprazole after single dose
Vd/F(Apparent volume of distribution)	Day1	Evaluation PK Rabeprazole after single dose
Cmax(Maximum concentration of drug in plasma)	Day1	Evaluation PK Rabeprazole after single dose
PTF(Peak trough fluctuation over one dosing interal at steady state)	From Day 1 up to Day 29	Evaluation PK Rabeprazole after multiple dose
After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours	Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring	Evaluation PD Rabeoprazoke
AUCtau(Area under the plasma drug concentration-time curve)	Day1	Evaluation PK Rabeprazole after single dose
Cmax,ss(Maximum concentration of drug in plasma at steady state)	From Day 1 up to Day 29	Evaluation PK Rabeprazole after multiple dose
After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours	Day1 24hours monitoring	Evaluation PD Rabeoprazoke
CL/F(Apparent clearance)	Day1	Evaluation PK Rabeprazole after single dose
Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)	From Day 1 up to Day 29	Evaluation PK Rabeprazole after multiple dose
Tmax,ss(Time to maximum plasma concentration at steady state)	From Day 1 up to Day 29	Evaluation PK Rabeprazole after multiple dose
t1/2,ss(Terminal elimination half-life at steady state)	From Day 1 up to Day 29	Evaluation PK Rabeprazole after multiple dose
CLss/F(Apparent Clearance at steady state)	From Day 1 up to Day 29	Evaluation PK Rabeprazole after multiple dose
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours	Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring	Evaluation PD Rabeoprazoke
Cav,ss(Average concentration of drug in plasma at steady state)	From Day 1 up to Day 29	Evaluation PK Rabeprazole after multiple dose
Vss/F(Apparent Volume of distribution at steady state)	From Day 1 up to Day 29	Evaluation PK Rabeprazole after multiple dose

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of